Staple cartridge tissue thickness sensor system

ABSTRACT

In various embodiments, a staple cartridge for use in a surgical stapler is disclosed. The staple cartridge comprises a staple body comprising a proximal end and a distal end. A tissue thickness sensing module is positioned adjacent to the distal end of the staple body. The tissue thickness sensing module comprises a controller and a sensor. A power key is located removably adjacent to the staple body. The controller is configured to detect the power key and to maintain the tissue thickness sensing module in a low-power state while the power key is present. When the power key is removed, the controller transitions the tissue thickness sensing module to an active state.

BACKGROUND

The present disclosure relates generally to surgical instruments forendoscopic, laparoscopic, or robotic surgery. Specifically, the presentdisclosure relates to surgical instruments comprising an end effectorconfigured to staple tissue.

Surgical staplers are used to simultaneously make a longitudinalincision in tissue and apply lines of staples on opposing sides of theincision. Such instruments commonly include an end effector having apair of cooperating jaw members that, if the instrument is intended forendoscopic or laparoscopic applications, are capable of passing througha cannula passageway. In one embodiment, one of the jaw members receivesa staple cartridge having at least two laterally spaced rows ofstaples—one on each side of a knife channel defined therein. The otherjaw member can define an anvil having staple-forming pockets alignedwith the rows of staples in the cartridge. The instrument can alsoinclude a plurality of cam, or lift, surfaces that, when drivendistally, pass through openings in the staple cartridge and engagedrivers supporting the staples to effect the firing of the staplestoward the anvil. Simultaneously, a cutting instrument (or knife) ismoved distally along the jaw member so that the clamped tissue is cutand fastened (e.g., stapled) at the same time.

An example of a surgical stapler suitable for endoscopic applications isdescribed in U.S. Pat. No. 7,000,818, entitled “Surgical StaplingInstrument Having Separate Distinct Closing and Firing Systems,” thedisclosure of which is herein incorporated by reference in its entirety.In use, a clinician is able to close the jaw members of the stapler upontissue to position the tissue prior to firing. Once the clinician hasdetermined that the jaw members are properly gripping tissue, theclinician can then fire the surgical stapler, thereby severing andstapling the tissue. The simultaneous severing and stapling actionsavoid complications that may arise when performing such actionssequentially with different surgical tools that respectively only severor staple.

Surgical staplers are configured to be used in an optimal tissuethickness range. Presently, clinicians must use video feeds andintuition to determine if the thickness of tissue clamped in the endeffector is within the optimal tissue thickness range. Developing aproper feel for the required thickness for a given cartridge type maytake years of practice or may never occur for some clinicians. What isneeded is a simple and reliable system for determining when the tissueclamped in an end effector is within the optimal tissue thickness rangefor a given staple cartridge.

SUMMARY

In various embodiments, a device comprising a Hall Effect sensor, a reedswitch, a power source, and a controller in signal communication withthe power source is disclosed. The controller is configured to detectthe state of the reed switch. A magnet is removably positioned adjacentto the device. The magnet is configured to generate a magnetic fieldsufficient to maintain the reed switch in a saturation state. Thecontroller detects the saturation state and maintains the device in alow-power state while the reed switch is in the saturation state. Whenthe magnet is removed from the device, the reed switch enters anon-saturated state. The controller detects the non-saturated state ofthe reed switch and transitions the device from the low-power state toan active power state.

In various embodiments, a surgical end effector is disclosed. Thesurgical end effector comprises a staple cartridge comprising a proximalend and a distal end. The staple cartridge is configured to be used tostaple tissue within an optimal tissue thickness range. An anvil ismovably coupled relative to the proximal end of the staple cartridge. Atissue thickness sensing module is located adjacent to the distal end ofthe staple cartridge. The tissue thickness sensing module comprises asensor and a controller. The sensor is configured to generate a tissuethickness signal indicative of a thickness of the tissue located betweenthe anvil and the staple cartridge. The controller is in signalcommunication with the sensor. The controller comprises means foridentifying the staple cartridge type of the staple cartridge. Thestaple cartridge type and the thickness of the tissue are used todetermine if the thickness of the tissue located between the anvil andthe staple cartridge is within the optimal tissue thickness range of thestaple cartridge.

In various embodiments, a staple cartridge for use in a surgical stapleris disclosed. The staple cartridge comprises a staple body comprising aproximal end and a distal end. A tissue thickness sensing module ispositioned adjacent to the distal end of the staple body. The tissuethickness sensing module comprises a controller and a sensor. A powerkey is located removably adjacent to the staple body. The controller isconfigured to detect the power key and to maintain the tissue thicknesssensing module in a low-power state while the power key is present. Whenthe power key is removed, the controller transitions the tissuethickness sensing module to an active state.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the various embodiments are set forth with particularityin the appended claims. The various embodiments, however, both as toorganization and methods of operation, together with advantages thereof,may best be understood by reference to the following description, takenin conjunction with the accompanying drawings as follows:

FIGS. 1 and 2 illustrate views of an articulating surgical instrument.

FIGS. 3-6 illustrate exploded views of the end effector and shaft of thesurgical instrument shown in FIGS. 1 and 2.

FIG. 7 illustrates a perspective view of an end effector comprising atissue thickness sensing module.

FIG. 8 illustrates one embodiment of a tissue thickness sensing module.

FIGS. 9A and 9B illustrate internal views of the tissue thicknesssensing module shown in FIG. 8.

FIG. 10 illustrates a block diagram of one embodiment of a tissuethickness sensing module.

FIG. 11 illustrates one embodiment of a tissue thickness sensing moduleconfigured to transmit a tissue thickness signal to a remote device.

FIG. 12 illustrates one embodiment of a tissue thickness sensing moduleconfigured to receive a power key comprising a magnet.

FIG. 13 illustrates one embodiment of Hall Effect sensor.

FIG. 14 illustrates one embodiment of a tissue thickness sensing moduleconfigured to receive a power key comprising terminal connectors.

FIG. 15 is a flow chart illustrating one embodiment of a method formaintaining a tissue thickness sensing module in a low-power state.

DETAILED DESCRIPTION

Applicant of the present application owns U.S. patent applicationentitled “Staple Cartridge Tissue Thickness Sensor System”, AttorneyDocket No. END7198USNP/120306, which was filed on even date herewith andwhich is herein incorporated by reference in its entirety.

Reference will now be made in detail to several embodiments, includingembodiments showing exemplary implementations of surgical instrumentscomprising a tissue thickness sensing module. Wherever practicablesimilar or like reference numbers may be used in the figures and mayindicate similar or like functionality. The figures depict exemplaryembodiments of the disclosed surgical instruments and/or methods of usefor purposes of illustration only. One skilled in the art will readilyrecognize from the following description that alternative exampleembodiments of the structures and methods illustrated herein may beemployed without departing from the principles described herein.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping the handle of aninstrument. Thus, the end effector is distal with respect to the moreproximal handle. It will be further appreciated that, for convenienceand clarity, spatial terms such as “vertical” and “horizontal” are usedherein with respect to the drawings. However, surgical instruments areused in many orientations and positions, and these terms are notintended to be limiting and absolute.

The instrument may be a motor-driven instrument, a hand-poweredinstrument, or a robotically controlled surgical instrument according tovarious embodiments. U.S. patent application Ser. No. 13/782,295,entitled “Articulatable Surgical Instruments With Conductive PathwaysFor Signal Communication”; U.S. patent application Ser. No. 13/782,323,entitled “Rotary Powered Articulation Joints For Surgical Instruments;U.S. patent application Ser. No. 13/782,338, entitled “Thumbwheel SwitchArrangements For Surgical Instruments”; U.S. patent application Ser. No.13/782,499, entitled “Electromechanical Surgical Device with SignalRelay Arrangement”; U.S. patent application Ser. No. 13/782,460,entitled “Multiple Processor Motor Control for Modular SurgicalInstruments”; U.S. patent application Ser. No. 13/782,358, entitled“Joystick Switch Assemblies For Surgical Instruments”; U.S. patentapplication Ser. No. 13/782,481, entitled “Sensor Straightened EndEffector During Removal Through Trocar”; U.S. patent application Ser.No. 13/782,518, entitled “Control Methods for Surgical Instruments withRemovable Implement Portions”; U.S. patent application Ser. No.13/782,375, entitled “Rotary Powered Surgical Instruments With MultipleDegrees of Freedom”; and U.S. patent application Ser. No. 13/782,536,entitled “Surgical Instrument Soft Stop”, which were filed on Mar. 1,2013, are hereby incorporated by reference in their entireties.

FIGS. 1 and 2 depict a motor-driven surgical cutting and fasteninginstrument 10 according to various embodiments of the presentdisclosure. The illustrated embodiment is a linear endoscopic instrumentand, in general, the embodiments of the instrument 10 described hereinare linear endoscopic surgical cutting and fastening instruments. Itshould be noted, however, that the invention is not so limited and thataccording to other embodiments of the present invention, the instrumentmay be another type of endoscopic instrument, such as a circular orcurved endocutter. U.S. Patent Application Publication No. 2008/0169332,published on Jul. 17, 2008, entitled “Surgical Stapling Device with aCurved Cutting Member”, is herein incorporated by reference in itsentirety. In addition, the instrument may be a non-endoscopic surgicalcutting and fastening instrument, such as a laparoscopic instrument, anopen surgery instrument, or a robotic surgical instrument. In someembodiments, the surgical instrument 10 may comprise recordingcapabilities. U.S. Pat. No. 7,845,537, which issued on Dec. 7, 2010,entitled “Surgical Instrument Having Recording Capabilities”, is hereinincorporated by reference in its entirety.

The surgical instrument 10 depicted in FIGS. 1 and 2 comprises a handle6, a shaft 8, and an end effector 12 connected to the shaft 8. Invarious embodiments, the end effector 12 can be articulated about anarticulation pivot 14. An articulation control 16 may be providedadjacent to the handle 6 to effect rotation of the end effector 12 aboutthe articulation pivot 14. In the illustrated embodiment, the endeffector 12 is configured to act as an endocutter for clamping, severingand stapling tissue, although, in other embodiments, different types ofend effectors may be used, such as end effectors for other types ofsurgical devices, such as graspers, cutters, staplers, clip appliers,access devices, drug/gene therapy devices, ultrasound, RF or laserdevices, etc.

The handle 6 of the instrument 10 may include a closure trigger 18 and afiring trigger 20 for actuating the end effector 12. It will beappreciated that instruments having end effectors directed to differentsurgical tasks may have different numbers or types of triggers or othersuitable controls for operating the end effector 12. The end effector 12is shown separated from the handle 6 by the elongate shaft 8. In oneembodiment, a clinician or operator of the instrument 10 may articulatethe end effector 12 relative to the shaft 8 by utilizing thearticulation control 16. U.S. Pat. No. 7,670,334, entitled “SurgicalInstrument Having an Articulating End Effector,” is incorporated hereinby reference in its entirety.

The end effector 12 may include, among other things, a staple channel 22and a pivotally translatable clamping member, such as an anvil 24, whichare maintained at a spacing that assures, when the anvil 24 is in itsclamped position, effective stapling and severing of tissue clamped inthe end effector 12. The handle 6 includes a downwardly extending pistolgrip 26, towards which a closure trigger 18 is pivotally drawn by theclinician to cause clamping or closing of the anvil 24 toward the staplechannel 22 of the end effector 12 to thereby clamp tissue positionedbetween the anvil 24 and channel 22. The firing trigger 20 is fartheroutboard of the closure trigger 18. Once the closure trigger 18 islocked in the closure position, the firing trigger 20 may rotateslightly toward the pistol grip 26 so that it can be reached by theoperator using one hand. Then the operator may pivotally draw the firingtrigger 20 toward the pistol grip 12 to cause the stapling and severingof clamped tissue in the end effector 12. In other embodiments,different types of clamping members besides the anvil 24 could be used.The handle 6 may also include an upper portion 28 that may sit on top ofthe user's hand when the user grips the pistol grip portion 26 withhis/her hand. The anvil 24 may include a magnet 78 located on the distalend of the anvil 24.

In operational use, the closure trigger 18 may be actuated first. Oncethe clinician is satisfied with the positioning of the end effector 12,the clinician may draw back the closure trigger 18 to its fully closed,locked position proximate to the pistol grip 26. Drawing back of theclosure trigger 18 causes the anvil 24 to rotate downwardly, clampingthe tissue between the anvil 24 and a staple cartridge 34 positionedwithin the channel 22. The firing trigger 20 may then be actuated.Actuation of the firing trigger 20 causes the cutting instrument in theend effector 12 to sever the clamped tissue, and causes the fasteners inthe staple cartridge 34 to fasten the severed tissue. The firing trigger20 returns to the open position (shown in FIGS. 1 and 2) when theclinician removes pressure. A release button 19 on the handle 6, whendepressed, may release the locked closure trigger 18. The release button19 may be implemented in various forms such as, for example, asdisclosed in U.S. Patent App. Pub. No. 2007/0175955. U.S. Patent App.Pub. No. 2007/0175955, entitled “Surgical cutting and fasteninginstrument with closure trigger locking mechanism,” is incorporatedherein by reference in its entirety.

The end effector 12 may include a cutting instrument, such as a knife,for example, for cutting tissue clamped in the end effector 12 when thefiring trigger 20 is retracted by a user. The end effector 12 may alsocomprise means for fastening the tissue severed by the cuttinginstrument, such as staples, RF electrodes, adhesives, etc. Theinstrument 10 may also comprise a closure system for closing (orclamping) the end effector upon closure (or retraction) of the closuretrigger 18.

A longitudinally movable or rotatable drive shaft located within theshaft 8 of the instrument 10 may drive or actuate the cutting instrumentand the fastening means in the end effector 12. An electric motor,located in the pistol grip portion 26 of the handle 6 of the instrument10, may be used to drive, directly or indirectly (via a gear drivetrain), the drive shaft. In various embodiments, the motor may be a DCbrushed driving motor having a maximum rotation of, approximately,25,000 RPM, for example. In other embodiments, the motor may include abrushless motor, a cordless motor, a synchronous motor, a stepper motor,or any other suitable electric motor. U.S. Patent ApplicationPublication No. 2010/0089970, published on Apr. 15, 2010, entitled“Powered Surgical Cutting and Stapling Apparatus with ManuallyRetractable Firing System” and U.S. Pat. No. 8,210,411, issued on Jul.3, 2012, entitled “Motor-Driven Surgical Cutting Instruments”, areherein incorporated by reference in their entireties. A battery (or“power source” or “power pack”), such as a Lithium-ion battery, forexample, may be provided in the pistol grip portion 26 of the handle 6adjacent to the motor. The battery may supply electric power to themotor via a motor control circuit. According to various embodiments, anumber of battery cells connected in series may be used as the powersource to power the motor. In addition, the power source may bereplaceable and/or rechargeable.

FIG. 3 is a diagram of the end effector 12 according to variousembodiments of the present invention. As shown in the illustratedembodiment, the end effector 12 may include, in addition to thepreviously mentioned channel 22 and anvil 24, a cutting instrument 32, asled 33, a staple cartridge 34 that is removably seated in the channel22, and a helical screw shaft 36. The cutting instrument 32 may be, forexample, a knife. The anvil 24 may be pivotably opened and closed atpivot pins 25 connected to the proximate end of the channel 22. Theanvil 24 may also include a tab 27 at its proximate end that is insertedinto a component of the mechanical closure system to open and close theanvil 24. When the closure trigger 18 is actuated, that is, drawn in bya user of the instrument 10, the anvil 24 may pivot about the pivot pins25 into the clamped or closed position, thereby clamping tissue betweenthe channel 22 and the anvil 24. If clamping of the end effector 12 issatisfactory, the operator may actuate the firing trigger 20, whichcauses the knife 32 and sled 33 to travel longitudinally along thechannel 22, thereby cutting the tissue clamped within the end effector12. The movement of the sled 33 along the channel 22 causes the staples(not shown) of the staple cartridge 34 to be driven through the severedtissue and against the closed anvil 24, which turns the staples tofasten the severed tissue. In various embodiments, the sled 33 may be anintegral component of the cartridge 34. The sled 33 may be part of thecartridge 34, such that when the knife 32 retracts following the cuttingoperation, the sled 33 does not retract with the knife 32 and remainswith the at least partially fired staple cartridge 34.

FIGS. 4-5 are exploded views and FIG. 6 is a side view of the endeffector 12 and shaft 8 according to various, non-limiting embodiments.As shown in the illustrated embodiment, the shaft 8 may include aproximate closure tube 40 and a distal closure tube 42 pivotably linkedby pivot links 44. The distal closure tube 42 includes an opening 45into which the tab 27 on the anvil 24 is inserted in order to open andclose the anvil 24, as further described below. Disposed inside theclosure tubes 40, 42 may be a proximate spine tube 46. Disposed insidethe proximate spine tube 46 may be a main rotational (or proximate)drive shaft 48 that communicates with a secondary (or distal) driveshaft 50 via a bevel gear assembly 52. The secondary drive shaft 50 isconnected to a drive gear 54 that engages a proximate drive gear 56 ofthe helical screw shaft 36. The vertical bevel gear 52 b may sit andpivot in an opening 57 in the distal end of the proximate spine tube 46.A distal spine tube 58 may be used to enclose the secondary drive shaft50 and the drive gears 54, 56. Collectively, the main drive shaft 48,the secondary drive shaft 50, and the articulation assembly (e.g., thebevel gear assembly 52 a-c) are sometimes referred to herein as the“main drive shaft assembly.”

A bearing 38, positioned at a distal end of the staple channel 22,receives the helical drive screw 36, allowing the helical drive screw 36to freely rotate with respect to the channel 22. The helical screw shaft36 may interface a threaded opening (not shown) of the knife 32 suchthat rotation of the shaft 36 causes the knife 32 to translate distallyor proximately (depending on the direction of the rotation) through thestaple channel 22. Accordingly, when the main drive shaft 48 is causedto rotate by actuation of the firing trigger 20, the bevel gear assembly52 a-c causes the secondary drive shaft 50 to rotate, which in turn,because of the engagement of the drive gears 54, 56, causes the helicalscrew shaft 36 to rotate, which causes the knife driving member 32 totravel longitudinally along the channel 22 to cut any tissue clampedwithin the end effector 12. The sled 33 may be made of, for example,plastic, and may have a sloped distal surface. As the sled 33 traversesthe channel 22, the sloped forward surface may push up or drive thestaples in the staple cartridge 34 through the clamped tissue andagainst the anvil 24. The anvil 24 turns or deforms the staples, therebystapling the severed tissue. When the knife 32 is retracted, the knife32 and sled 33 may become disengaged, thereby leaving the sled 33 at thedistal end of the channel 22.

In the illustrated embodiment, the end effector 12 uses a rotatable,helical screw shaft 36 to drive the cutting instrument 32. Such ahelical screw shaft 36 may be used in embodiments where a rotating drivemember is used. In other embodiments, a longitudinally reciprocatingdrive member may be used to power the cutting instrument, such as, forexample, the longitudinally reciprocating drive member. The end effector12 may be modified accordingly to suit such a longitudinallyreciprocating drive member.

According to various embodiments, the staple cartridge 34 may comprise atissue thickness sensing module 102 that senses the thickness of tissueclamped in the end effector 12 between the staple channel 22 (includingthe staple cartridge 34) and the anvil 24. According to various,non-limiting embodiments, as shown in FIG. 7, the tissue thicknesssensing module 102 may be located adjacent to a distal end 62 of thestaple cartridge 34, such that it is positioned distally, for example,with respect to the staples of the staple cartridge 34 when the staplesare fired. FIGS. 8-9B show one embodiment of a tissue thickness sensingmodule 102. As shown in FIG. 8, the tissue thickness sensing module 102may comprise an enclosure 103 to protect the elements of the tissuethickness sensing module 102 during use. FIGS. 9A and 9B illustrate oneview of the tissue thickness sensing module 102 with the enclosure 103removed. As can be seen in FIGS. 9A and 9B, the tissue thickness sensingmodule 102 may comprise a tissue thickness sensor 104, a controller 106,a radio module 108, a power source 110, and an antenna 112.

In some embodiments, the tissue thickness sensor 104 may be configuredto generate a tissue thickness signal indicative of a thickness oftissue clamped between the staple channel 22 and the anvil 24. Thetissue thickness sensor 104 may be any suitable sensor for detecting thethickness of the tissue clamped in the end effector 12. For example, thetissue thickness sensor 104 may comprise a magnetic sensor,magneto-inductive sensor, a magnetoresistive sensor (AMR, GMR), anultrasonic sensor, a radio frequency sensor, and/or any other suitablesensor. In some embodiments, the tissue thickness sensor 104 may beconfigured to detect a magnetic field generated by the magnet 78 locatedon the distal end 80 of the anvil 24. When the clinician closes theanvil 24 by retracting the closure trigger 18, the magnet 78 rotatesdownwardly closer to the tissue thickness sensor 104, thereby varyingthe magnetic field detected by the tissue thickness sensor 104 as theanvil 24 rotates into the closed (or clamped position). The strength ofthe magnetic field from the magnet 78 and sensed by the tissue thicknesssensor 104 is indicative of the distance between the staple cartridge 34and the anvil 24, which is indicative of the thickness of the tissueclamped between the staple cartridge 34 and the anvil 24 when the endeffector 12 is in the closed (or clamped) position. For instance, alarger distance between the staple cartridge 34 and the anvil 24, andtherefore a weaker magnetic field detected by the tissue thicknesssensor 104, may indicate that thick tissue is present between the staplecartridge 34 and the anvil 24, while a shorter distance between thestaple cartridge 34 and the anvil 24, and therefore a stronger magneticfield detected by the tissue thickness sensor 104, may indicate thatthin tissue is present between the staple cartridge 34 and the anvil 24.In some embodiments, the tissue thickness sensor 104 may comprise a HallEffect sensor.

A controller 106 may be configured to control one or more operations ofthe tissue thickness sensing module 102. The controller 106 may be insignal communication with the tissue thickness sensor 104. Signalcommunication may comprise wired and/or wireless communication. Thecontroller 106 may be configured to control operation of the tissuethickness sensor 104, the transmitter 108, and/or the power source 110.In some embodiments, the controller 106 may be configured to execute oneor more processes to control the tissue thickness sensing module 102and/or the end effector 12.

In some embodiments, the controller 106 may comprise identifying meansfor identifying the type of staple cartridge positioned within thestaple channel 22. The staple cartridge 34 may be configured for usewithin an optimal tissue thickness range and the controller 106 may beconfigured to determine whether or not a particular staple cartridge issuitable and/or preferred in a given set of circumstances. For example,in some embodiments, a staple cartridge 34 may comprise a plurality oflong staples configured for use in thick tissue. In some embodiments, astaple cartridge 34 may comprise a plurality of short staples configuredfor use in thin tissue. When the optimal tissue thickness range for thestaple cartridge 34 mandates or prefers the use of longer staples, anattempt to use a staple cartridge configured for use in thin tissue maycause the surgical instrument 2 to warn the clinician, for example, orin some instances, prevent the surgical instrument 2 from being used.The identifying means may be configured to identify the type of thestaple cartridge positioned within the staple channel 22 to ensure theproper type of staple cartridge 34 is installed for the tissue beingtreated.

In some embodiments, the tissue thickness sensing module 102 maycomprise a radio module 108. The radio module 108 may be a low-power,2-way radio module that communicates wirelessly, using a wireless datacommunication protocol, with a remote device, such as, for example, areceiver located in the handle 6 of the instrument 10. According tovarious embodiments, the radio module 108 may communicate with theremote device using a communication frequency that is suitable fortransmission through human tissue. The communications between the radiomodule 108 and remote device may use the MICS (Medial ImplantCommunication Service) frequency band (502-405 MHz), a suitableindustrial, scientific and medical (ISM) radio band (such as 433 MHzcenter frequency or 915 MHz center frequency), a Bluetooth communicationband (2.4 GHz), or any other suitable, human-tissue-permeable frequencyband. In some embodiments, an antenna 112 may be in signal communicationwith the radio module 108. In some embodiments, the antenna 112 may beformed integrally with the radio module 108.

The tissue thickness sensing module 102 may comprise one or more powersources 110 for providing independent power to the controller 106 or theradio module 108. The power source 110 may comprise a suitable batterycell for powering the components of the tissue thickness sensing module102, such as a Lithium-ion battery or some other suitable battery cell,for example. In some embodiments, multiple battery cells may be providedto power the components of the tissue thickness sensing module 102.

In some embodiments, the staple cartridge type signal generated by theidentifying means and the tissue thickness signal generated by thetissue thickness sensor 104 may be used to determine if the tissueclamped between the staple channel 22 and the anvil 24 is within theoptimal tissue thickness range for the staple cartridge 34. In someembodiments controller 106 may be configured to determine if the tissueclamped between the staple channel 22 and the anvil 24 is within theoptimal tissue thickness range. In some embodiments, a remote system,such as a remote device located in the handle 6 of the surgicalinstrument 10, may be configured to perform the determination or atleast part of such determination.

FIG. 10 shows a block diagram of one embodiment of a tissue thicknesssensing module 202. In the illustrated embodiment, the tissue thicknesssensing module 202 comprises a tissue thickness sensor 204, a controller206, a radio module 208, and a power source 210, and a reed switch 211.As shown in FIG. 10, the tissue thickness sensor 204 may be in signalcommunication with the controller 206. The tissue thickness sensor 204may be any suitable sensor for determining the thickness of tissueclamped between the staple channel 22 and the anvil 24 of the surgicalinstrument 10. In some embodiments, the tissue thickness sensor 204 maybe configured to detect a magnetic field generated by a magnet 78located on the distal end 80 of the anvil 24. The strength of themagnetic field may be indicative of the thickness of tissue clamped inthe end effector 12. In some embodiments, the tissue thickness sensor204 may comprise a Hall Effect sensor.

The controller 206 illustrated in FIG. 10 may comprise an identifiermeans 214 for identifying the staple cartridge type of the staplecartridge 34. The identifier means 214 may be any suitable means useableby the controller 206 to identify the staple cartridge type. Forexample, in some embodiments, the identifying means 214 may comprise amemory unit. The memory unit of the controller 206 may comprise one ormore solid state read only memory (ROM) and/or random access memory(RAM) units. In various embodiments, the controller 206 and the memoryunits may be integrated into a single integrated circuit (IC), ormultiple ICs. The ROM memory units may comprise flash memory. The memoryunit may store data indicative of the cartridge type of the staplecartridge 34. That is, for example, memory unit may store dataindicating the type of staple cartridge 34. In some embodiments, thememory unit may store data indicative of the optimal tissue thicknessrange of the type of the staple cartridge 34.

In some embodiments, the identifying means 214 may comprise a firstplurality of terminals formed on the proximal end of the tissuethickness sensing module 102. A second plurality of terminals may beformed on the distal end of the staple cartridge 34. A subset of thefirst plurality of terminals may be in signal communication with thesecond plurality of terminals. The type of the staple cartridge 34 maybe indicated by the subset of the first plurality of terminals that arein signal communication with the second plurality of terminals. One ormore circuits may be configured to identify the subset of the firstplurality of terminals in signal communication and provide a staplecartridge type signal to the controller 106 based on the identifiedsubset.

In various embodiments, the tissue thickness signal generated by thetissue thickness sensor 204 and the staple cartridge type signalgenerated by the identifying means 214 may be used to determine if thethickness of the tissue clamped in the end effector 12, as indicated bythe tissue thickness signal, is within the optimal tissue thicknessrange of the staple cartridge 34, as indicated by the staple cartridgetype signal. For example, the thickness of the tissue as indicated bythe tissue thickness signal may be compared to an optimal tissuethickness range for the staple cartridge 34. In some embodiments, thecontroller 206 may be configured to determine if the measured thicknessis within the optimal tissue thickness range. For example, thecontroller 206 may comprise a memory unit configured to store staplecartridge types and their associated optimal tissue thickness ranges.When the tissue thickness sensing module 202 enters an active state, theidentifying means 214 may provide a staple cartridge type signal to thecontroller 206. When tissue is clamped in the end effector 12, thecontroller 206 may receive a tissue thickness signal from the tissuethickness sensor 204 indicating the thickness of the tissue clamped inthe end effector 12. The controller 206 may access the memory unit andcompare the staple cartridge type signal generated by the identifyingmeans 214 with the stored staple cartridge types. If the staplecartridge type of the staple cartridge 34 matches a staple cartridgetype stored in the memory unit, the controller 206 may access the storedoptimal tissue thickness range for the staple cartridge 34. Thecontroller 206 may compare the stored optimal tissue thickness range forthe staple cartridge 34 with the tissue thickness indicated by thetissue thickness sensor 204 and may generate a status signal indicatingwhether the measured tissue thickness is within the optimal tissuethickness range of the staple cartridge 34. The controller 206 mayprovide the status signal to the radio module 208 for transmission. Insome embodiments, the radio module 208 may transmit the status signal toa receiver located in the handle 6 of the surgical instrument 10. Insome embodiments, the radio module 208 may transmit the status signal toa receiver coupled to a remote device, such as, for example, anoperating room video display 80 comprising a receiver 82 or a remotecomputer system 84 comprising a receiver 86 (see FIG. 11).

The staple cartridge 34 may comprise a staple cartridge type notrecognized by the identifying means 214. In some embodiments, if theidentifying means 214 is unable to identify the staple cartridge 34inserted into the staple channel 22, the controller 206 may provide awarning to the clinician indicating that the staple cartridge isunrecognized. The warning may be any suitable warning, such as, forexample, an audible warning, a visual warning, and/or a tactile warning.The warning may indicate to the clinician that the staple cartridge 34is not recognized and that the clinician must use their discretion inthe use and deployment of the inserted staple cartridge 34.

The optimal tissue thickness range for a specific staple cartridge maycomprise an open-ended range. For example, in some embodiments, anoptimal tissue thickness range for a specific staple cartridge maycomprise any tissue thickness that is less than a maximum tissuethickness. In other embodiments, the optimal tissue thickness range fora specific staple cartridge may comprise any tissue thickness that isgreater than a minimum tissue thickness. For example, a staple cartridgemay comprise long staples suitable for stapling thick tissue or thintissue. The optimal tissue thickness range for this staple cartridge maybe any tissue thickness that is less than the maximum tissue thicknessfor the staple cartridge.

In some embodiments, the staple cartridge 34 may comprise a universalstaple cartridge suitable for use in any thickness of tissue. If theidentifying means 214 identifies a universal staple cartridge, thecontroller 206 may provide a signal to the clinician indicating that thestaple cartridge 34 is a universal cartridge and therefore the thicknessof tissue located between the anvil 24 and the staple cartridge 34should not affect the operation of the surgical instrument 2.

As an example, a staple cartridge 34 may be located adjacent to a tissuethickness sensing module 202. The staple cartridge 34 and the tissuethickness sensing module may be inserted into the staple channel 22. Theidentifying means may identify the staple cartridge 34 as a cartridgehaving an optimal tissue thickness range between a first value, x1, anda second value x2. Tissue may be clamped by a clinician between theanvil 24 and the staple cartridge 34. The tissue thickness sensor 204may generate a tissue thickness signal indicating that the thickness ofthe tissue clamped between the anvil 24 and the staple cartridge 34 isx. In some embodiments, the tissue thickness x may fall within theoptimal tissue thickness range x1-x2 and the tissue thickness sensingmodule 202 may provide an indication to the clinician that the tissuethickness x is within the optimal tissue thickness range.

In some embodiments, the tissue thickness x may fall outside the optimaltissue thickness range for the staple cartridge 34. For example, thetissue thickness x may be thinner than the lower value x1 of the optimaltissue thickness range. The surgical instrument 2 may provide a warningsignal to the clinician that the tissue thickness x is lower than theoptimal tissue thickness range. The surgical instrument 2 may stillallow stapling if the measured tissue thickness x is thinner than theoptimal tissue thickness range. As another example, the tissue thicknessx may be thicker than the upper value x2 of the optimal tissue thicknessrange. The surgical instrument 2 may provide a warning to the clinicianthat the tissue thickness x is thicker than the optimal tissue thicknessrange. In some embodiments, the surgical instrument 2 may prevent firingthe staple cartridge 34 if the measured tissue thickness x is thickerthan the optimal tissue thickness range. In some embodiments, thesurgical instrument may instruct the clinician to replace the staplecartridge 34 with a different cartridge type having a different optimaltissue thickness range.

In some embodiments, the controller 206 may be configured to provide thetissue thickness signal and the staple cartridge type signal to theradio module 208 for transmission to a remote device. The radio module208 may transmit the tissue thickness signal and the staple cartridgetype signal to a remote device located away from the end effector 12,such as, for example, a control circuit in the handle 6 of the surgicalinstrument 10 or a remote computer system 84. The remote device may beconfigured to perform a comparison between the received tissue thicknesssignal, the received staple cartridge type signal, and known optimaltissue thickness ranges. For example, the remote device may beconfigured to store known staple cartridges and optimal tissue thicknessranges for the known staple cartridges. The received staple cartridgetype signal may be compared to the known staple cartridges. If a matchis identified, the received tissue thickness signal may be compared tothe optimal tissue thickness range for the staple cartridge 34. Theremote device may generate a status signal indicating whether themeasured tissue thickness, as indicated by the tissue thickness signal,is within the optimal tissue thickness range for the staple cartridge34. The remote device may be updated, such as, for example, through aconnection to a wired and/or wireless network. The remote device may beupdated to add new staple cartridge types and optimal tissue thicknessranges or may be updated to adjust the optimal tissue thickness range ofexisting staple cartridge types. By updating the remote device, staplecartridge types can be added or updated without the need to update thetissue thickness sensing module 202. In some embodiments, the remotedevice may receive updates periodically or may be updated whenever a newor modified cartridge is available.

In some embodiments, after the status signal has been generated byeither the controller 206 or the remote device, the status signal may beused to control operation of the surgical instrument 10. For example,the status signal may be provided to a motor control circuit in thehandle 6 of the surgical instrument 10. The motor control circuit may beconfigured to control a cutting and sealing operation of the surgicalinstrument 10. If the status signal indicates that the measured tissuethickness is within the optimal tissue thickness range for the staplecartridge 34, the motor control circuit may allow the cutting andsealing operation to occur. If the status signal indicates that themeasured tissue thickness is not within the optimal tissue thicknessrange for the staple cartridge 34, the motor control circuit may preventoperation of the cutting and sealing operation and may provide a warningto the clinician indicating that the tissue thickness is not within theoptimal tissue thickness range.

In some embodiments, the status signal may be displayed to a clinicianthrough a feedback device. The feedback device may be located on thesurgical instrument 10 or may be a remote device, such as an operatingroom video display 80. For example, in some embodiments, the surgicalinstrument 10 may be equipped with a light-emitting diode (LED). The LEDmay be activated when the status signal indicates that the tissueclamped in the end effector 12 has a thickness within the optimal tissuethickness range of the staple cartridge 34. As another example, theoperating room video display 80 may be configured to display a graphicalrepresentation of the status signal, such as, for example, displaying anindicator when the measured tissue thickness is within the optimaltissue thickness range. Those skilled in the art will recognize that anysuitable feedback device may be used to provide the status signal to aclinician. In some embodiments, the surgical instrument 2 may comprise adisplay window on the surgical instrument 2. The display window may beconfigured to display a representation of the status signal or thetissue thickness signal to a clinician. The display window may providean indication of the measured tissue thickness and the optimal tissuethickness range of the staple cartridge 34.

In some embodiments, the tissue thickness sensing module 102 may beconfigured to receive a power key. The power key may be configured tocontrol operation of the tissue thickness sensing module 102 prior toinstallation of the staple cartridge 34 into the staple channel 22. Forexample, in some embodiments the tissue thickness sensing module 102 maycomprise a power source 110. The power source 110 may be in signalcommunication with the controller 106. The controller 106 may detect thepresence of the power key and may maintain the power source 110 and thetissue thickness sensing module 102 in a low-power state to conserve theavailable energy from the power source 110.

FIG. 12 illustrates one embodiment of a thickness sensing module 302configured to receive a power key 320. The power key 320 may comprise amagnet 378 configured to maintain the tissue thickness sensor 104 in asaturation state when the power key 320 is located adjacent to and/orconnected with the tissue thickness sensing module 302. The controller106 may detect the saturation state of the tissue thickness sensor 104and may maintain the tissue thickness sensing module 302 in a low-powerstate while the tissue thickness sensor 104 is in the saturation state.The low-power state may comprise a state in which various modules of thetissue thickness sensing module 302 do not receive power or in whichvarious operations of the tissue thickness sensing module 302 are notperformed. For example, the low-power state may disconnect thecontroller 106, the radio module 108, and/or the tissue thickness sensor104 from the power source 110. When the power key 320 is detached ormoved away from the tissue thickness sensing module 302, the tissuethickness sensor 104 may enter a non-saturated state. When thecontroller 106 detects the non-saturated state, the controller 106 maytransition the tissue thickness sensing module 302 into an active statefor use in the surgical instrument 10. The active state may comprise astate in which all modules and functions of the tissue thickness sensingmodule 302 are provided with power and are operational.

In some embodiments, a device may comprise a reed switch, a powersource, and a controller in signal communication with the power source.The controller may be configured to detect the state of the reed switch.A magnet may be removably located adjacent to the device. The magnet maybe configured to generate a magnetic field sufficient to maintain thereed switch in a saturation state. The controller may detect thesaturation state and may maintain the device in a low-power state whilethe reed switch is in the saturation state. When the magnet is removedfrom the device, the reed switch may enter a non-saturated state. Thecontroller may detect the non-saturated state of the reed switch andtransition the device from the low-power state to an active power state.

FIG. 13 illustrates one embodiment of a Hall Effect sensor 402. The HallEffect sensor 402 comprises a Hall Element 404, an amplifier 406, and apower source 408. The Hall Element comprises a first input terminal 410and a second input terminal 412. The first and second input terminals410, 412 are configured to receive a constant input current from thepower source 408. When no magnetic field is present, the input currententers the first input terminal 410 and exits the second input terminal412 with no loss of voltage potential to either side of the Hall Element404. As a magnetic field is applied to the Hall Element 404, such as,for example, by magnet 478, a voltage potential is formed at the sidesof the Hall Element 404 due to the deflection of electrons flowingthrough the Hall Element 404. A first output terminal 414 and a secondoutput terminal 416 are located at opposite sides of the Hall Element404. The first and second output terminals 414, 416 provide the voltagepotential caused by the magnetic field to the amplifier 406. Theamplifier 406 amplifies the voltage potential experienced by the HallElement 404 and outputs the amplified voltage to an output terminal 418.The output of the amplifier 406 may not exceed the limits imposed by thepower source 408. The upper limit of the amplifier 406 is the saturationpoint for the Hall Effect sensor 402. The saturation point may beselected based on the power source 408 connected to the amplifier 406.Because the saturation takes place at the amplifier 406, and not at theHall Element 404, exposure to large magnetic filed will not damage theHall Effect sensor 402, but instead places the Hall Effect sensor 402into a saturation state. In some embodiments, an open emitter, an opencollector, or a push-pull transistor may be added to the output of theamplifier 406.

FIG. 14 illustrates one embodiment of tissue thickness sensing module502 configured to receive a power key 520. The tissue thickness sensingmodule 502 may comprise a first terminal 516 and a second terminal 518configured to receive the power key 520. The first terminal 516 and thesecond terminal 518 may be in signal communication with the controller106. The power key 520 may be configured to create a first electricalcircuit state between the first terminal 516 and the second terminal518. The first electrical circuit state may be any suitable statebetween the first terminal 516 and the second terminal 518, such as, forexample, an open circuit, a short circuit, a specific resistance,capacitance, inductance, or any other suitable circuit state. In someembodiments, the controller 106 may detect the first electrical circuitstate between the first terminal 516 and the second terminal 518 andmaintain the tissue thickness sensing module 502 in a low-power state.In some embodiments, the first electrical circuit state may prevent thepower source 110 from providing power to the elements of the tissuethickness sensing module 502, such as through an open circuit, andprevent operation of the controller 106, radio module 108, or otherpowered elements while the power key 520 is present.

In some embodiments, the removal of the power key 520 from the firstterminal 516 and the second terminal 518 may create a second electricalcircuit state between the first terminal 516 and the second terminal518. The second electrical circuit state may be any suitable circuitstate between the first terminal 516 and the second terminal 518, suchas, for example, an open circuit or a short circuit. The controller 106may detect the second electrical circuit state and may transition thetissue thickness sensing module 502 into an active power state foroperation with the surgical instrument 10.

For example, in some embodiments the power key 520 may be configured tocreate a short circuit between the first terminal 516 and the secondterminal 518. The controller 106 may detect the short circuit betweenthe first terminal 516 and the second terminal 518. The controller 106may maintain the tissue thickness sensing module 502 in a low-powerstate to conserve the power source 110 while a short circuit existsbetween the first terminal 516 and the second terminal 518. Prior toinstallation of the staple cartridge 34 into the staple channel 22, thepower key 520 may be removed from the tissue thickness sensing module502. When the power key 520 is removed from the tissue thickness sensingmodule 502, the circuit between the first terminal 516 and the secondterminal 518 may be opened. The controller 106 may detect the opencircuit between the first terminal 516 and the second terminal 518 andmay transition the tissue thickness sensing module 502 into an activestate.

As another example, in some embodiments, the power key 520 may beconfigured to maintain an open circuit between the first terminal 516and the second terminal 518. The power source 110 may be disconnectedfrom the controller 106 and the radio module 108 when the first terminal516 and the second terminal 518 are in an open circuit state. The staplecartridge 34 may be inserted into the staple channel 22. Once installed,a clinician may remove the power key 520 from the tissue thicknesssensing module 502. When the power key 520 is removed, the circuitbetween the first terminal 516 and the second terminal 518 may becompleted by a direct connection between the first terminal 516 and thesecond terminal 518 or through an indirect connection, such as throughthe staple cartridge 34, the staple channel 22, or any other suitableportion of the end effector 12. For example, the first terminal 516 andthe second terminal 518 may comprise a short circuit when the staplecartridge 34 is installed in the staple channel 22 and the power key 520is removed from the tissue thickness sensing module 502. The shortcircuit between the first terminal 516 and the second terminal 518 mayconnect the power source 110 to the controller 106 and the radio module108, causing the tissue thickness sensing module 502 to transition to anactive state for use with the surgical instrument 10.

FIG. 15 illustrates a flow chart showing one embodiment of a method formaintaining the tissue thickness sensing module 102 in a low-powerstate. As shown in FIG. 15, at step 602 a controller 106 may detect astaple cartridge power key 320, 520 removably adjacent to a tissuethickness sensing module 102. The controller 106 may detect the staplecartridge power key, such as power key 320, 520 for example, through anysuitable method, such as, for example, a circuit state or a sensorstate. At step 604, the controller 106 maintains the tissue thicknesssensing module 102 in a low-power state while the staple cartridge powerkey is located adjacent to, or attached to, the tissue thickness sensingmodule 102. At 606, the staple cartridge power key is removed from thetissue thickness sensing module 102. The controller 106 detects theremoval of the staple cartridge power key and transitions the tissuethickness sensing module 102 from a low-power state to an active stateat step 608.

In some embodiments, a tissue thickness sensing module 302 may comprisea tissue thickness sensor 104 configured to detect a magnetic field,such as a Hall Effect sensor, for example. The staple cartridge powerkey 320 may be located adjacent to the tissue thickness sensing module302 and may comprise a magnet 378 configured to place the tissuethickness sensor 104 into a saturation state. In some embodiments, atstep 604, the controller 106 in the tissue thickness sensing module 302may detect the saturation state of the tissue thickness sensor 104. Thecontroller 106 may maintain the tissue thickness sensing module 302 inthe low-power state while the tissue thickness sensor 104 is in thesaturation state. The staple cartridge power key 320 may be removed fromthe tissue thickness sensing module 302. The tissue thickness sensor 104may transition from the saturation state to a non-saturated state. Thecontroller 106 may detect the non-saturated state of the tissuethickness sensor 104 and may transition the tissue thickness sensingmodule 302 from the low-power state to an active state.

In some embodiments, the tissue thickness sensing module 502 maycomprise a first terminal 516 and a second terminal 518 formed on theenclosure of the tissue thickness sensing module 502. The first terminal516 and the second terminal 518 may be configured to receive the powerkey 520. The power key 520 may create a first electrical circuit statebetween the first terminal 516 and the second terminal 518. For example,the first electrical circuit state may comprise an open circuit or ashort circuit. At step 604, the controller 106 may be configured todetect the presence of the power key 520 based on the first electricalcircuit state. The controller 106 may maintain the tissue thicknesssensing module 502 in a low-power state while the first terminal 516 andthe second terminal 518 are in the first electrical circuit state. Thepower key 520 may be removed from the tissue thickness sensing module502 to allow the staple cartridge 34 to be installed into the staplechannel 22. In some embodiments, removing the power key 520 may causethe first terminal 516 and the second terminal 518 to transition to asecond electrical circuit state, such as, a short circuit or an opencircuit. The controller 106 may detect the second electrical circuitstate and transition the tissue thickness sensing module 502 from thelow-power state to an active state.

While various embodiments of a tissue thickness sensing module disclosedherein comprise a wireless transmitter and a power source, otherembodiments are envisioned. For instance, in one embodiment, at leastone conductor, such as a wire, for example, may extend through the shaftof the surgical instrument and may provide signal communication and/orpower communication from the handle to the tissue thickness sensingmodule. In some embodiments, the controller and/or the power source maybe located in the handle and may be connected to the tissue thicknesssensing module through a wired connection to the controller, the powersource, and/or any other components located in the handle.

While various embodiments of a tissue thickness sensing module disclosedherein are positioned distally with respect to a staple cartridge,various other embodiments are envisioned in which the tissue thicknesssensing module can be positioned laterally, proximally, and/or distallywith respect to a staple cartridge. In certain embodiments, a pluralityof tissue thickness sensing modules can be utilized. In suchembodiments, a microcontroller can be configured to interpret aplurality of tissue thickness signals from a plurality of tissuethickness sensing modules to derive the thickness of the tissue.

Various embodiments described herein are described in the context ofstaples removably stored within staple cartridges for use with surgicalstapling instruments. In some circumstances, staples can include wireswhich are deformed when they contact an anvil of the surgical stapler.Such wires can be comprised of metal, such as stainless steel, forexample, and/or any other suitable material. Such embodiments, and theteachings thereof, can be applied to embodiments which include fastenersremovably stored with fastener cartridges for use with any suitablefastening instrument.

Various embodiments described herein are described in the context oflinear end effectors and/or linear fastener cartridges. Suchembodiments, and the teachings thereof, can be applied to non-linear endeffectors and/or non-linear fastener cartridges, such as, for example,circular and/or contoured end effectors. For example, various endeffectors, including non-linear end effectors, are disclosed in U.S.patent application Ser. No. 13/036,647, filed Feb. 28, 2011, entitledSURGICAL STAPLING INSTRUMENT, now U.S. Patent Application PublicationNo. 2011/0226837, which is hereby incorporated by reference in itsentirety. Additionally, U.S. patent application Ser. No. 12/893,461,filed Sep. 29, 2012, entitled STAPLE CARTRIDGE, now U.S. PatentApplication Publication No. 2012/0074198, is hereby incorporated byreference in its entirety. U.S. patent application Ser. No. 12/031,873,filed Feb. 15, 2008, entitled END EFFECTORS FOR A SURGICAL CUTTING ANDSTAPLING INSTRUMENT, now U.S. Pat. No. 7,980,443, is also herebyincorporated by reference in its entirety. U.S. Pat. No. 8,393,514,entitled SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE, whichissued on Mar. 12, 2013, is also hereby incorporated by reference in itsentirety.

EXAMPLES

In various embodiments, a surgical end effector for treating tissue isdisclosed. The surgical end effector comprises a staple cartridge. Thestaple cartridge comprises a proximal end and a distal end. The staplecartridge is configured to be used to staple tissue within an optimaltissue thickness range. An anvil is movably coupled relative to theproximal end of the staple cartridge. A tissue thickness sensing moduleis adjacent to the distal end of the staple cartridge. The tissuethickness sensing module comprises a sensor and a controller. The sensoris configured to generate a tissue thickness signal indicative of athickness of the tissue located between the anvil and the staplecartridge. The controller is in signal communication with the sensor.The controller comprises identifying means for identifying a staplecartridge type. The staple cartridge type and the tissue thicknesssignal are used to determine if the thickness is within the optimaltissue thickness range.

In some embodiments, the anvil comprises a magnet. The sensor may beconfigured to detect a magnetic field generated by the magnet. Thesensor may comprise a Hall Effect sensor. In some embodiments, thethickness sensing module comprises a transmitter in signal communicationwith the controller. The transmitter may be configured to transmit thestaple cartridge type and the tissue thickness signal to a receiver. Thestaple cartridge type and the tissue thickness signal may be received bya receiver in a surgical instrument. The receiver determines if thethickness measurement is within the optimal tissue thickness range.

In some embodiments, the controller may be configured to generate asignal indicative of whether the thickness measurement is within theoptimal tissue thickness range. The transmitter may be configured totransmit the signal. In some embodiments, the thickness sensing modulemay comprise at least one power source configured to supply power to thecontroller.

In some embodiments, the identifying means may comprise a memory unitcoupled to the controller. The memory unit may be configured to storethe staple cartridge type. In some embodiments, the identifier means maycomprise a first plurality of terminals located on the tissue thicknesssensing module and a second plurality of terminals located on the distalend of the staple cartridge. A subset of the first plurality ofterminals is in signal communication with the second plurality ofterminals. The staple cartridge type is determined by the subset of thefirst plurality of terminals in signal communication with the secondplurality of terminals. In some embodiments, the tissue thicknesssensing module may be configured to receive a power key. The tissuethickness sensing module may comprise a first terminal and a secondterminal. The first terminal and the second terminal may be configuredto receive a power key configured to maintain the tissue thicknesssensing module in a low-power state.

In various embodiments, a staple cartridge for use in a surgical stapleris disclosed. The staple cartridge comprises a staple body comprising aproximal end and a distal end. A plurality of staples is removablystored within the staple body. The plurality of staples is configured tobe used to staple tissue within an optimal tissue thickness range. Atissue thickness module is adjacent to the distal end of the staplechannel. The tissue thickness module comprises a sensor and acontroller. The sensor is configured to generate a tissue thicknesssignal indicative of a thickness of the tissue located between the anviland the staple cartridge. The controller is in signal communication withthe sensor. The controller comprises identifying means for identifying astaple cartridge type. The staple cartridge type and the tissuethickness signal are used to determine if the thickness of the tissue iswithin the optimal tissue thickness range.

In some embodiments the thickness sensing module comprises a transmitterin signal communication with the controller and at least one powersource configured to supply power to the controller and the transmitter.The transmitter may be configured to transmit the staple cartridge typeand the tissue thickness signal. The staple cartridge type and thetissue thickness signal may be received by a receiver in a surgicalinstrument. The receiver determines if the thickness of the tissue iswithin the optimal tissue thickness range. In some embodiments, thecontroller is configured to generate a signal indicative of whether thethickness of the tissue is within the optimal tissue thickness range.The transmitter may be configured to transmit the signal.

In some embodiments, the identifier means may comprise a memory unit insignal communication with the controller. The memory unit is configuredto store the staple cartridge type. In some embodiments, the identifiermeans may comprises a first plurality of terminals located on the tissuethickness sensing module and a second plurality of terminals located onthe distal end of the staple cartridge. A subset of the first pluralityof terminals may be in signal communication with the second plurality ofterminals. The staple cartridge type is determined by the subset of thefirst plurality of terminals in signal communication with the secondplurality of terminals.

In some embodiments, the sensor may comprise a Hall Effect sensor. Insome embodiments, the tissue thickness sensing module may be configuredto receive a removable power key. The power key may be configured tomaintain the tissue thickness sensing module in a low-power state. Theremovable power key may comprise a magnet configured to maintain thesensor in a saturation state. The low-power state may be maintainedwhile the sensor is in the saturation state.

In various embodiments, a tissue thickness sensing module for attachmentto a surgical staple cartridge configured for treatment of tissue isdisclosed. The tissue thickness sensing module comprises a sensor and acontroller. The sensor is configured to detect a magnetic fieldindicative of a thickness of the tissue clamped against the surgicalstaple cartridge. The control is in signal communication with thesensor. The controller comprises an identifier means for identifying astaple cartridge type. The staple cartridge type and the thickness ofthe tissue are used to determine if the thickness is within an optimaltissue thickness range for the surgical staple cartridge. A transmitteris in signal communication with the controller. At least one powersource is configured to supply power to the controller and thetransmitter.

In various embodiments, a staple cartridge for use in a surgical stapleris disclosed. The staple cartridge comprises a staple body comprising aproximal end and a distal end. A tissue thickness sensing module iscoupled to the distal end of the staple body. The tissue thicknesssensing module comprises a controller and a sensor. A power key isremovably positioned relative to the tissue thickness sensing module.The controller is configured to detect the power key. When thecontroller detects the power key, the controller maintains the tissuethickness sensing module in a low-power state. When the power key isremoved, the controller transitions the tissue thickness sensing moduleto an active state.

In some embodiments, the sensor comprises a Hall Effect sensor and thepower key comprises a magnet. The magnet is configured to maintain theHall Effect sensor in a saturation state when the power key ispositioned relative to the tissue thickness sensing module. Thecontroller detects the saturation state of the Hall Effect sensor andmaintains the low-power state while the Hall Effect sensor is in thesaturation state. When the power key is removed from the tissuethickness sensing module, the Hall Effect sensor transitions to anon-saturated state. The controller detects the non-saturated state ofthe Hall Effect sensor and transitions the tissue thickness sensingmodule to the active state.

In some embodiments, the staple cartridge comprises a first terminal anda second terminal. The power key creates a first electrical circuitstate between the first terminal and the second terminal. The controllerdetects the first electrical circuit state and maintains the tissuethickness sensing module in the low-power state while the first terminaland the second terminal are in the first electrical circuit state. Whenthe power key is removed from the tissue thickness sensing module, thefirst terminal and the second terminal transition to a second electricalcircuit state. The controller detects the second electrical circuitstate and transitions the tissue thickness sensing module to the activestate.

In some embodiments, the first electrical circuit state comprises ashort circuit between the first terminal and the second terminal and thesecond electrical circuit state comprises an open circuit between thefirst terminal and the second terminal. In some embodiments, the firstelectrical circuit state comprises an open circuit between the firstterminal and the second terminal and the second electrical circuit statecomprises a short circuit between the first terminal and the secondterminal. The short circuit between the first terminal and the secondterminal may be established by a connection between the staple cartridgeand a surgical stapler when the staple cartridge is inserted into thesurgical stapler.

In various embodiments, a device comprising a Hall Effect sensor, apower source, and a controller is disclosed. The controller isconfigured to receive power from the power source. The controller isconfigured to maintain the device in a low-power state when the reedswitch is in a saturation state. The controller is configured totransition the device to an active state when the Hall Effect sensor isin a non-saturation state.

In various embodiments, a method for power management of a staplecartridge assembly having a tissue thickness sensing module isdisclosed. The method comprises detecting, by a controller, a power keyremovably positioned adjacent to the tissue thickness sensing module.The method further comprises maintaining, by the controller, a tissuethickness sensing module in a low-power state when the power key isdetected. The controller transitions to an active state when the powerkey is removed from the tissue thickness sensing module.

In some embodiments, sensing the power key may comprise detecting, bythe controller, a state of a sensor. The state of the sensor indicateswhether the power key is positioned relative to said tissue thicknesssensing module. The sensor may comprise a Hall Effect sensor. The stateof the sensor may comprise a saturation state. In some embodiments,sensing of the power key may comprise detecting, by the controller, afirst electrical circuit state between a first terminal and a secondterminal. The first electrical circuit state indicates that the powerkey is positioned relative to the tissue thickness sensing module. Thecontroller may be configured to detect a second electrical circuit statebetween the first terminal and the second terminal. The secondelectrical circuit state indicates that the power key is not positionedrelative to the tissue thickness sensing module.

In some embodiments, the first electrical circuit state may comprise ashort circuit across the first terminal and the second terminal and thesecond electrical circuit state may comprise an open circuit between thefirst terminal and the second terminal. In some embodiments, the firstelectrical circuit state may comprise an open circuit between the firstterminal and the second terminal and the second electrical circuit statemay comprise a short circuit across the first terminal and the secondterminal.

In some embodiments, the method may further comprise inserting thestaple cartridge into a surgical stapler. The power key may be removedfrom the tissue thickness sensing module. The surgical stapler maycomplete a circuit connection between the first terminal and the secondterminal.

In various embodiments, a method for controlling a device comprising acontroller, a power source, and a reed switch is disclosed. The methodcomprises detecting, by the controller, a saturation state of the reedswitch. The reed switch is maintained in the saturation state by a powerkey positioned relative to the reed switch. The power key comprises amagnet configured to generate a magnetic field sufficient to place thereed switch in the saturation state. The method further comprisesmaintaining, by the controller, the device in a locked state while thereed switch is in the saturation state. The locked state comprises alow-power state of the device. The method further comprisestransitioning, by the controller, the device to an unlocked state,wherein the transition occurs when the power key is removed from thereed switch and the reed switch transitions to a non-saturated state.The unlocked state comprises an active state of the device.

Various embodiments of surgical instruments and robotic surgical systemsare described herein. It will be understood by those skilled in the artthat the various embodiments described herein may be used with thedescribed surgical instruments and robotic surgical systems. Thedescriptions are provided for example only, and those skilled in the artwill understand that the disclosed embodiments are not limited to onlythe devices disclosed herein, but may be used with any compatiblesurgical instrument or robotic surgical system.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one example embodiment,” or “an embodiment” means that aparticular feature, structure, or characteristic described in connectionwith the embodiment is included in at least one example embodiment.Thus, appearances of the phrases “in various embodiments,” “in someembodiments,” “in one example embodiment,” or “in an embodiment” inplaces throughout the specification are not necessarily all referring tothe same embodiment. Furthermore, the particular features, structures,or characteristics illustrated or described in connection with oneexample embodiment may be combined, in whole or in part, with features,structures, or characteristics of one or more other embodiments withoutlimitation.

While various embodiments herein have been illustrated by description ofseveral embodiments and while the illustrative embodiments have beendescribed in considerable detail, it is not the intention of theapplicant to restrict or in any way limit the scope of the appendedclaims to such detail. Additional advantages and modifications mayreadily appear to those skilled in the art. For example, each of thedisclosed embodiments may be employed in endoscopic procedures,laparoscopic procedures, as well as open procedures, without limitationsto its intended use.

It is to be understood that at least some of the figures anddescriptions herein have been simplified to illustrate elements that arerelevant for a clear understanding of the disclosure, while eliminating,for purposes of clarity, other elements. Those of ordinary skill in theart will recognize, however, that these and other elements may bedesirable.

While several embodiments have been described, it should be apparent,however, that various modifications, alterations and adaptations tothose embodiments may occur to persons skilled in the art with theattainment of some or all of the advantages of the disclosure. Forexample, according to various embodiments, a single component may bereplaced by multiple components, and multiple components may be replacedby a single component, to perform a given function or functions. Thisapplication is therefore intended to cover all such modifications,alterations and adaptations without departing from the scope and spiritof the disclosure as defined by the appended claims.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

What is claimed is:
 1. A staple cartridge for use in a surgical stapler, the staple cartridge comprising: a staple body comprising a proximal end and a distal end; a tissue thickness sensing module coupled to said distal end of said staple body, wherein said tissue thickness sensing module comprises: a controller; and a sensor; and a power key removably positioned relative to said tissue thickness sensing module, wherein said controller is configured to detect said power key, wherein, when said controller detects said power key, said controller maintains said tissue thickness sensing module in a low-power state, and wherein, when said power key is removed, said controller transitions said tissue thickness sensing module to an active state.
 2. The staple cartridge of claim 1, wherein: said sensor comprises a Hall Effect sensor; and wherein said power key comprises a magnet, wherein said magnet is configured to maintain said Hall Effect sensor in a saturation state when said power key is positioned relative to said tissue thickness sensing module, and wherein said controller detects said saturation state of said Hall Effect sensor and maintains said low-power state while said Hall Effect sensor is in said saturation state.
 3. The staple cartridge of claim 2, wherein, when said power key is removed from said tissue thickness sensing module, said Hall Effect sensor transitions to a non-saturated state, and wherein said controller detects said non-saturated state of said Hall Effect sensor and transitions said tissue thickness sensing module to said active state.
 4. The staple cartridge of claim 1, comprising: a first terminal and a second terminal; wherein said power key creates a first electrical circuit state between said first terminal and said second terminal, wherein said controller detects said first electrical circuit state and maintains said low-power state while said first terminal and said second terminal are in said first electrical circuit state.
 5. The staple cartridge of claim 4, wherein, when said power key is removed from said tissue thickness sensing module, said first terminal and said second terminal transition to a second electrical circuit state, and wherein said controller detects said second electrical circuit state and transitions said tissue thickness sensing module to said active state.
 6. The staple cartridge of claim 5, wherein said first electrical circuit state comprises a short circuit between said first terminal and said second terminal, and wherein said second electrical circuit state comprises an open circuit between said first terminal and said second terminal.
 7. The staple cartridge of claim 5, wherein said first electrical circuit state comprises an open circuit between said first terminal and said second terminal, and wherein said second electrical circuit state comprises a short between said first terminal and said second terminal.
 8. The staple cartridge of claim 7, wherein said short between said first terminal and said second terminal is established by a connection between said staple cartridge and a surgical stapler when said staple cartridge is inserted into said surgical stapler.
 9. A device comprising: a reed switch; a power source; and a controller configured to receive power from said power source, wherein said controller is configured to maintain said device in a low-power state when said reed switch is in a saturation state, and wherein said controller is configured to transition said device to an active state when said reed switch is in a non-saturation state.
 10. A method for power management of a staple cartridge assembly having a tissue thickness sensing module, the method comprising: detecting, by a controller, a power key removably positioned adjacent to said tissue thickness sensing module; maintaining, by said controller, a tissue thickness sensing module in a low-power state when said power key is detected; and transitioning, by said controller, said tissue thickness sensing module to an active state when said power key is removed from said tissue thickness sensing module.
 11. The method of claim 10, wherein said sensing of said power key comprises: detecting, by said controller, a state of a sensor, wherein said state of said sensor indicates said power key is positioned relative to said tissue thickness sensing module.
 12. The method of claim 11, wherein said sensor comprises a reed switch and said state comprises a saturation state.
 13. The method of claim 10, wherein said sensing of said power key comprises: detecting, by said controller, a first electrical circuit state between a first terminal and a second terminal, wherein said first electrical circuit state indicates that said power key is positioned relative to said tissue thickness sensing module.
 14. The method of claim 13, comprising: detecting, by said controller, a second electrical circuit state between said first terminal and said second terminal, wherein said second electrical circuit state indicates that said power key is not positioned relative to said tissue thickness sensing module.
 15. The method of claim 14, wherein said first electrical circuit state comprises a short circuit across said first terminal and said second terminal, and wherein said second electrical circuit state comprises an open circuit between said first terminal and said second terminal.
 16. The method of claim 14, wherein said first electrical circuit state comprises an open circuit between said first terminal and said second terminal, and wherein said second electrical circuit state comprises a short circuit across said first terminal and said second terminal.
 17. The method of claim 16, comprising: inserting said staple cartridge into a surgical stapler; removing said power key from said tissue thickness sensing module; and completing, by said surgical stapler, a circuit connection between said first terminal and said second terminal.
 18. A method for controlling a device comprising a controller, a power source, and a reed switch sensor, the method comprising: detecting, by said controller, a saturation state of said reed witch, wherein said reed switch is maintained in said saturation state by a power key positioned relative to said reed switch, and wherein said power key comprises a magnet configured to generate a magnetic field sufficient to place said reed switch in said saturation state; maintaining, by said controller, said device in a locked state while said reed switch is in said saturation state, wherein said locked state comprises a low-power state of said device; and transitioning, by said controller, said device to an unlocked state, wherein said transition occurs when said power key is removed from said reed switch and said reed switch is in a non-saturated state, and wherein said unlocked state comprises an active state of said device. 